Patient leaflet - Deflazacort 6 mg tablets, Calcort 6 mg tablets
1. What Calcort is and what it is used for
Noticeable blood vessels, thinning of the skin.
- These illnesses can be serious.
2. Before you take Calcort
Sudden or severe muscle weakness or tiredness following
- Usually they start within a few days or weeks of starting
3. How to take Calcort
an operation.
the medicine.
4. Possible side effects
Some of the side effects are more likely to happen if you are elderly.
- They are more likely to happen at high doses.
5. How to store Calcort
- Most of these problems go away if the dose is lowered or
6. Further information
the medicine is stopped.
Children and teenagers taking this medicine may grow 
less than normal. (Not known: frequency cannot be estimated from the available data).
However, if problems do happen, they might need treatment.
- 1.
What Calcort is and what it is used for
Talk to a doctor if you (or someone taking this medicine), show any signs of mental problems.
Calcort is a steroid medicine. Their full name is glucocorticoids.
If you think this is happening to a child, tell your doctor.
This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.
Reporting of side effects
How Calcort works
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
These corticosteroids occur naturally in the body, and help
to maintain health and wellbeing.
Check with your doctor before taking this medicine if:
Boosting your body with extra corticosteroid (such as
Calcort) is an effective way to treat various illnesses involving inflammation in the body.
- You have epilepsy (fits).
- You or anyone in your family has diabetes.
Calcort works by reducing this inflammation, which could
- You have high blood pressure.
otherwise go on making your condition worse.
- You have liver or heart problems.
You have kidney problems or high levels of uric acid in
your blood before initiating Calcort. You should tell your doctor if you have any symptoms of tumour lysis syndrome such as muscle cramping, muscle weakness, confusion, visual loss or disturbances, shortness of breath, seizures, irregular heartbeat or kidney failure (reduced amount or darkening of urine), in case you suffer from haematological malignancy (see section 4. ‘Possible side effects’).
- You have brittle or weak bones called osteoporosis.
You have an eye disease that causes detachment of your
retina and bulging eyes.
You or anyone in your family has an eye problem called
glaucoma.
- You have an underactive thyroid gland.
You have problems with your digestive system, including
your food pipe (oesophagitis), gut (ulcerative colitis, diverticulitis) or stomach (peptic ulcer).
You have ever had a bad reaction such as muscle
weakness to any steroid.
You have or ever had an infection caused by a virus or
fungus. This includes infections such as athlete’s foot, thrush and cold sores (that may also affect the eye).
- You have or ever had ‘tuberculosis’ (TB).
You have any problems with your blood vessels such as a
blood clot.
You have a pheochromocytoma (a tumour of adrenal
gland tissue. The adrenal glands are located above the kidneys.).
Calcort may cause inflammation of tendons and easy tearing especially when given together with antibiotics such as ciprofloxacin.
Irregular periods in women and blood problems such as leukocytosis (increase in white blood cells count) may also occur.
If any of the above apply to you, your doctor may want to see you more often during your treatment.
Contact your doctor if you experience blurred vision or other visual disturbances.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you obtain without a prescription, including herbal medicines. This is because Calcort and other medicines can affect the way some other medicines work.
Some medicines may increase the effects of Calcort and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
In particular, check with your doctor if you are taking any of the following medicines. Your doctor may want to change the dose of Calcort, or the other medicine.
- Painkillers such as aspirin.
- Aminoglutethimide – used for some types of cancer.
- Ketoconazole – used to treat infections.
Water tablets (diuretics) such as spironolactone,
triamterene or amiloride.
- Medicines for thinning your blood (such as warfarin).
- Medicines for diabetes.
Medicines for epilepsy such as phenobarbitone,
primidone, phenytoin, carbamazepine, acetazolamide.
Medicines which contain oestrogens including oral
contraceptives.
Medicines for tuberculosis (TB) such as rifampicin or
rifabutin.
- Medicines for high blood pressure.
Medicines for indigestion and heartburn (antacids). If you
are taking an antacid leave at least 2 hours between taking it and Calcort.
Medicines for asthma such as salbutamol and
theophylline.
Vaccinations
If you have just had any injections or vaccinations, tell your doctor before you take Calcort. If you are going to have any injections or vaccinations, tell your doctor or nurse you are taking Calcort. This includes those needed for a foreign holiday. Some vaccines should not be given to patients taking Calcort. This is because Calcort can affect the way some vaccines work.
Operations
If you are going to have an operation, tell your doctor or nurse you are taking Calcort. Muscle relaxants are sometimes used during an operation or in intensive care unit. Calcort and muscle relaxants can affect one another.
Pregnancy and breast-feeding
Talk to your doctor before taking Calcort if:
You are pregnant, plan to get pregnant, or think you may
be pregnant.
- You are breast-feeding, or planning to breast-feed.
Driving and using machines
These tablets may make you feel dizzy, feel like everything around you is spinning, or feel disorientated (vertigo). If this happens, do not drive or use any tools or machines.
Adults
The usual dose for most conditions, including rheumatoid
arthritis is half to three tablets each day.
The dose for severe asthma may be up to 8 or 12 tablets
each day. This dose may be gradually reduced once the asthma attack has been controlled.
For some problems up to 20 tablets may be needed each
day for several days.
Children
- Calcort may be given every day or every other day.
The doctor will work out the dose based on your child’s
age and weight.
- Your child will be given the lowest possible dose.
The usual dose for chronic arthritis is between 0.25mg and
1mg of the medicine for each kg of your child’s bodyweight, each day.
The usual dose for kidney problems (nephrotic syndrome) is 1.5mg of the medicine for each kg of your child’s bodyweight, each day. Depending on how well the medicine works for your child, this dose may then be slowly lowered.
The usual dose for asthma is between 0.25mg and 1mg of
the medicine for each kg of your child’s bodyweight, every other day.
In infants, an echocardiogram (ultrasound) should be
performed by the doctor to monitor the structure and function of the muscular tissue of the heart.
Calcort and infections
Taking Calcort can mean that you get infections more easily than usual, and these infections can be more serious.
Elderly
Your doctor may need to check you more carefully for side effects.
Chickenpox, measles or shingles
If you get chickenpox, measles or shingles while taking Calcort, you can become seriously ill.
Keep away from people who have chickenpox, measles or
shingles, if you have never had them. They could affect you severely. If you do come into contact with chickenpox, measles or shingles, see your doctor straight away. Your doctor may want to give you a vaccination to help you from getting these infections.
If you do catch Chickenpox, measles or shingles, tell your
doctor straight away. Your doctor will advise you on how to take Calcort. You may be told to increase the number of tablets that you use.
Blue steroid card
If you take this medicine for more than three weeks, you
will be given a blue ‘steroid card’ by your doctor or pharmacist.
It contains information about your medicine, including
dose instructions. This is important if you fall ill or are in an accident.
- You should carry the card with you at all times.
Important information about some ingredients in Calcort
This medicine contains lactose. If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking this medicine.
If you take more Calcort than you should
Tell your doctor or go to the nearest hospital casualty department straight away. Remember to take with you any tablets that are left and the pack. This is so the doctor knows what you have taken.
If you forget to take Calcort
If you forget to take a dose take it as soon as you remember, unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.
Stopping treatment
You need to take Calcort regularly to get the maximum
benefit.
Do not stop taking this medicine without talking to your
doctor - you may need to lower the dose gradually.
Stopping the treatment suddenly can sometimes cause
problems such as a high temperature, a runny nose, sore, red, sticky eyes, aching muscles and joints, itchy skin and weight loss. Also, sickness (vomiting), headaches and drowsiness – this is more likely to happen in children.
You may also notice the following symptoms if you stop treatment with Calcort. If this happens, tell a doctor straight away as these could be signs of a serious illness:
- Sudden, severe pain in the back, stomach and legs.
- Being sick (vomiting) and diarrhoea.
Feeling faint or dizzy, this could be a sign of low blood
pressure.
- How to take Calcort 4. Possible side effects
Always take Calcort exactly as your doctor has told you. The dose will depend on the illness being treated and any other medicines you are taking. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
- Take this medicine by mouth.
- Swallow your tablets whole with a glass of water.
It is important to take your medicine at the right times.
Like all medicines, Calcort can cause side effects, although not everybody gets them.
Stop taking your medicine and see a doctor or go to a hospital straight away if:
- You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to Calcort.
- You pass black tarry stools or notice fresh or clotted blood in your stools (faeces). You may also notice dark bits that look like coffee grounds in your vomit. These could be signs of a stomach ulcer.
Not known (frequency cannot be estimated from the available data)
- You get severe stomach pain which may reach through to your back. This could be a sign of pancreatitis.
Serious effects: Tell a doctor straight away if you notice any of the following side effects: Steroids including Calcort can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like Calcort.
Serious effects: Tell a doctor straight away if you notice any of the following side effects.
- Feeling depressed, including thinking about suicide.
Not known (frequency cannot be estimated from the available data)
- Feeling high (mania) or moods that go up and down.
- Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory.
Feeling, seeing or hearing things which do not exist.
Having strange and frightening thoughts, changing how you act or having feelings of being alone.
- Pheochromocytoma crisis (symptoms can include an awareness of your heart beat, increase in heart rate (palpitations), excessive sweating, high blood pressure, severe headaches or have a tremor (feeling shaky)).
- Cases of tumour lysis syndrome have been reported in patients suffering from haematological malignancy. Tumour lysis syndrome may be revealed by your doctor based on changes in blood tests such as increased levels of uric acid, potassium, or phosphorus, and decreased level of calcium, and may result in symptoms such as muscle cramping, muscle weakness, confusion, visual loss or disturbances, shortness of breath, seizures, irregular heartbeat or kidney failure (reduced amount or darkening of urine). If you experience such symptoms, you must tell your doctor immediately (see section 2. ‘Warnings and precautions’).
Other serious side effects include:
Not known (frequency cannot be estimated from the available data)
- A very sore throat. You may also have difficulty in swallowing and the inside of your mouth may have white areas on the surface.
- Headache, which is usually worse in the morning, on coughing or straining, and feeling sick (nausea). Also, fits, fainting, eyesight problems, painful eyes or confusion can occur.
In infants with a low birth weight a heart muscle disease
(hypertrophic cardiomyopathy) may occur. If you notice any of these problems talk to a doctor straight away.